Z-1693-2020 Class II Terminated
FDA device recall Z-1693-2020 was initiated by Medtronic Navigation, Inc. on August 28, 2019 and is designated Class II. Reason for recall: Product was incorrectly assembled which could affect navigation accuracy of the device. The recall status is terminated (terminated May 5, 2021). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2020
- Initiation Date
- August 28, 2019
- Termination Date
- May 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
NavLock Tracker *** Rx Only
Reason for Recall
Product was incorrectly assembled which could affect navigation accuracy of the device.
Distribution Pattern
U.S.: NY No O.U.S.
Code Information
Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585